Tazobactam

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

The PEC values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, not all medicinal products containing the same active substance.

Assessment report Zerbaxa from 2015

Assessment report for tazobactam from Zerbaxa (ceftozolane, tazobactam), 23 July 2015, EMA/CHMP/388494/2015.

Hazard

Persistence: DT_{50, whole system} = 12 days, Shifting to sediment = 7%.

Bioaccumulation: Log D_OW = -0.63.

Toxicity: There are data for 3 trophic levels, most sensitive algae NOEC (Anabaena flos-aquae = cyanobacteria) EC₁₀ 399 mikrog/L.

Risk

The risk, PEC/PNEC, calculated in the assessment report from a European perspective:

PEC_Surfacewater = 0.285 microg/L.

PNEC = Lowest NOEC 399 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 39.9 microg/L

PEC/PNEC = 0.007 which gives the risk insignificant. "No risk. The use of EC₁₀ is discussed below." Nothing has been found about this in the document.

Assessment report Zerbaxa from 2019

Assessment report for tazobactam from Zerbaxa (ceftozolane, tazobactam), 25 July 2019, EMA/463294/2019 for extension of indications.

Hazard

Persistence: No new data.

Bioaccumulation: Log D_OW = -0.63 at pH 7.4.

Toxicity: No new data.

Risk

The risk, PEC/PNEC, calculated in the assessment report from a European perspective:

PEC_Surfacewater = 15 microg/L.

PNEC = Lowest NOEC 399 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 39.9 microg/L

PEC/PNEC = 0.4 which gives the risk low.

Fass environmental information

Fass environmental information for tazobactam from Zerbaxa from MSD (downloaded 2024-01-24).

Hazard

Persistence: "Sediment Transformation (OECD 308) ... Half-life = 5–12 days in total water-sediment systems. ... Since half-life < 32 days for total system, the substance is degraded in the environment."

Bioaccumulation: "Partitioning coefficient (OECD 107) ... Log K = -0.63 at 7."

Toxicity: There are data for 3 trophic levels, most sensitive algae (Anabaena flos-aquae) NOEC 440 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 0.0025 which gives the risk insignificant.